Safety and Pharmacokinetics of a Single Oral TPN171H in Healthy Elderly Subjects

NCT06090136 | Completed Phase 1

• 1 other identifier: TPN171H-06
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

It is a single-center, open-label, Phase I clinical study evaluating the safety and pharmacokinetics of a single oral TPN171H in elderly subjects.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (12)

• Adverse events

  Number of Participants With treatment-related Adverse Events and Serious Adverse Events

  7 days after dosing

• Pharmacokinetic parameter of TPN171H:Tmax

  Pharmacokinetic parameter of TPN171H:Tmax

  48 hours after dosing

• Pharmacokinetic parameter of TPN171H:Cmax

  Pharmacokinetic parameter of TPN171H:Cmax

  48 hours after dosing

• Pharmacokinetic parameter of TPN171H:T1/2

  Pharmacokinetic parameter of TPN171H:T1/2

  48 hours after dosing

• Pharmacokinetic parameter of TPN171H:AUC0-t

  Pharmacokinetic parameter of TPN171H:AUC0-t

  48 hours after dosing

• Pharmacokinetic parameter of TPN171H:AUC0-∞

  Pharmacokinetic parameter of TPN171H:AUC0-∞

  48 hours after dosing

• Pharmacokinetic parameter of TPN171H:AUC0-24h

  Pharmacokinetic parameter of TPN171H:AUC0-24h

  48 hours after dosing

• Pharmacokinetic parameter of TPN171H:Ke

  Pharmacokinetic parameter of TPN171H:Ke

  48 hours after dosing

• Pharmacokinetic parameter of TPN171H:Vd

  Pharmacokinetic parameter of TPN171H:Vd

  48 hours after dosing

• Pharmacokinetic parameter of TPN171H:MRT

  Pharmacokinetic parameter of TPN171H:MRT

  48 hours after dosing

• Pharmacokinetic parameter of TPN171H:CL/F

  Pharmacokinetic parameter of TPN171H:CL/F

  48 hours after dosing

• Pharmacokinetic parameter of TPN171H:BRPP

  Pharmacokinetic parameter of TPN171H:BRPP

  48 hours after dosing

Study Arms (1)

TPN171H

EXPERIMENTAL

5 mg TPN171H tablets，single dose,oral

Drug: TPN171H

Interventions

TPN171H DRUG

5 mg TPN171H tablets，single dose,oral

TPN171H

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 65 years old；
• Male≥50kg，femal≥45kg, Body mass index should be between 18 and 30 kg/m2 (inclusive)；
• No major organ dysfunction；normal heart, liver and kidney function;
• Physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry), 12 lead ECG, Abdominal ultrasound, chest X-ray results were normal or abnormal but investigator judged suitable for participating in this trial;
• Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent

You may not qualify if:

• Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases;
• Surgical condition or condition that may significantly affect ADME of the drug, urgical condition or condition that may pose a hazard if the subject participating in the study
• With a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinopathy (e.g. Retinitis pigmentosa), and macular degeneration；
• A history of sudden decrease or loss of hearing；
• A history of postural hypotension；
• Participated in other drug clinical trials or medical devices clinical trials within 3 months before administration；
• Drink alcohol at least 2 times a day or more than 14 times a week in the 6 months prior to enrollment or alcoholics(Drink alcoholics defined as 125 mL of wine, 220 mL of beer, or liquor50mL； Alcoholism is defined as 5 or more drinks in approximately 2 hours) ;
• A history of drug use or have been screened positive for drug abuse;
• hepatitis B surface antigen (HBsAg),hepatitis C virus antibody,treponema pallidum antibody,Human immunodeficiency virus antibody (HIV)positive;
• Other factors that the investigator considered inappropriate for the study.

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Gangyi Liu

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: October 19, 2023
• Study Start: September 14, 2020
• Primary Completion: December 14, 2020
• Study Completion: July 22, 2022
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)